NCT04335851

Brief Summary

Both influenza and coronaviruses cause respiratory infections, which can lead to morbidity and mortality, especially in those who are immunocompromised or not immune to viruses (Zhu). Physical exercise has many effects on the human body, including the immune system. Moderate exercise appears to have a beneficial effect on immune function, which can protect against upper respiratory infections. Human being is a social entity by nature and social isolation can negatively affect individuals' psychology. There are many studies examining the effect of physical activity on the mental state of people. The World Health Organization (WHO) suggests individual protection measures such as establishing necessary hygienic conditions, ensuring social isolation and keeping immune system strong against the complications that may develop due to Coronavirus.Human being is a social entity by nature and social isolation can negatively affect individuals' psychology. There are many studies examining the effect of physical activity on the mental state of people. Different theories which claims the psychological improvements resulting from the increased levels of physical activity have also been proposed in the literature.Regular aerobic exercise and walking can not only improve the emotional state of the individuals, but may also affect the mental health by avoiding the negative thoughts and adapting to stress. The aim of this study is to increase the physical activity level, psychological condition and physical well-being with video-based exercises.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

April 2, 2020

Last Update Submit

June 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • World Health Organization Quality of Life Questionnaire Bref

    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Turkish version of WHOQoL- BREF will be used in the study.The WHOQOL-BREF produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score.

    2 months

Secondary Outcomes (2)

  • Rapid Assessment of Physical Activity

    2 months

  • Global Rating of Change Scale

    2 months

Study Arms (2)

Physical Activity Group

EXPERIMENTAL

Individuals in this group will be given "walk at home" exercise video made by American Hearth Association. Videos for each week will be chosen by therapist. They will be asked to do exercise 3 days a week for 4 weeks by following the videos. The intensity and duration of the exercises will be gradually increased by therapists each week. Exercise follow-ups will be done over the phone and by asking individuals to keep an exercise diary.

Other: Video based aerobic exercise

Control Group

NO INTERVENTION

Physically inactive individuals will be included to study as control. Individuals will be asked to continue their daily routines.

Interventions

During social isolation induced by COVID-19, physically inactive people will do exercise in company with aerobic exercises named videos"walk at home" which made by American Heart Association. 3 days a week in total 4 weeks. Each sessions will last approximately 30-40 minutes.

Physical Activity Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • who haven't been exercising before and also not thinking of exercising during the isolation period
  • Who are willing to exercise during the isolation

You may not qualify if:

  • Having a disease that may interfere or aggravated with exercise such as orthopaedic problems, chronic diseases, etc.
  • Having difficulty of understanding and following video-based exercises
  • Having diagnose of any kind of psychiatric condition such as major depression, panic attack, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Social IsolationSedentary Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Ayşe Zengin Alpözgen, Assistant Professor, PhD

    Istanbul University - Cerrahpasa

    STUDY CHAIR
  • Begum Kara Kaya, MSc

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 6, 2020

Study Start

April 6, 2020

Primary Completion

May 15, 2020

Study Completion

June 3, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations